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Asian Journal of Pharmaceutical Analysis
Year : 2018, Volume : 8, Issue : 2
First page : ( 109) Last page : ( 116)
Print ISSN : 2231-5667. Online ISSN : 2231-5675.
Article DOI : 10.5958/2231-5675.2018.00021.2

Validation of Analytical Procedures-A Review

Sahoo Chinmaya Keshari1,*, Sudhakar Muvvala2, Ramana D. Venkata3, Satyanarayana K.4, Panda Kanhu Charan5

1Assistant Professor, Department of Pharmaceutics, Malla Reddy College of Pharmacy (Affiliated to Osmania University), Maisammaguda, Secunderabad, Telangana-500014

2Professor and Principal, Department of Pharmaceutics, Malla Reddy College of Pharmacy (Affiliated to Osmania University), Maisammaguda, Secunderabad, Telangana-500014

3Professor, Department of Pharmaceutical Technology, Netaji Institute of Pharmaceutical Sciences, Toopranpet, Yadadri Bhongir, Telangana-508252

4Professor and Principal, Department of Pharmacognosy, Princeton College of Pharmacy, Korremula, Ghatkesar, R.R. District, Telangana-500088

5Associate Professor, Department of Pharmaceutics, Anwarul Uloom College of Pharmacy, New mallepally, Hyderabad, Telangana

*Corresponding Author E-mail: sahoo.chinmaya83@gmail.com

Online published on 7 July, 2018.

Abstract

The development of analytical method is important during the process of drug discovery, release to market and development, culminating in market approval. The method development, optimization and validation of the drug product from the development stage of the formulation to commercial batch of product is essential. Method development for the finished product or in process tests and sample preparation drug product is to provide practical approaches for determining selectivity, specificity, limit of detection, limit of quantitation, linearity, range, accuracy, precision, recovery solution stability, ruggedness, robustness etc. This review article explains about the strategy and importance of validation of analytical methods.

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Keywords

Analytical method, Linearity, Range, Accuracy, Precision.

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